柯惠Pipeline脑⾎管⽀架
Pipeline?
Embolization Device
The power to rede?ne aneurysm treatment.
REDEFINE
The Pipeline? device rede?nes treatment for
large or giant wide-necked aneurysms by
reconstructing the parent artery and
restoring its natural cour. PRE-TREATMENT
6-MONTH FOLLOW-UP
1 YEAR FOLLOW-UP The power to rede?ne
aneurysm treatment.
3 YEAR FOLLOW-UP
Images courtesy of Henry Woo, MD
Pipeline ? Device Technology
As the ?rst approved ?ow diverter in the US market, the Pipeline device provides the power to achieve unparalleled long-term clinical success in the treatment of large or giant wide-necked aneurysms.
Image from preclinical study. Scanning electron microscopy
(SEM) of rabbit vertebral artery shows that the aneurysmal
neck was completely occluded with neointima. The lumbar arteries, vertebral artery, and other branc
hes were all patent.1 Rede?ne:
Aneurysm Treatment & Outcomes
Reconstruct the parent artery and avoid intrasaccular manipulation
t Optimized radial force and ?exibility
— 48-strand braided mesh design for ?exible conformability
— 75% cobalt chromium/25% platinum tungsten for radial force and uniform radiopacity t Braided mesh design creates scaffolding for endothelial repavement
t Ability to telescope multiple devices for variable degrees of surface coverage or to create longer constructs
Remodel the vesl while keeping perforators open
t Optimized ?ow diversion
— 30-35% surface coverage at nominal diameter 1t Perforators stay open 1
The Pipeline ? device is the most effective long-term solution for treatment of large or giant wide-necked aneurysms.
Long-Term Follow-Up
Large ophthalmic aneurysm treated with the Pipeline device.
PRE-TREATMENT 1 YEAR FOLLOW-UP 3 YEAR FOLLOW-UP
Images courtesy of Henry Woo, MD
Complete and Durable Occlusion
Large ophthalmic aneurysm treated with the Pipeline device.
PRE-TREATMENT 1 YEAR FOLLOW-UP 3 YEAR FOLLOW-UP
Images courtesy of Tibor Becske, MD
and Peter Kim Nelson, MD
The PUFs trial proved the safety and ef?cacy of the Pipeline ? device for treatment of large or giant wide-necked aneurysms.2
ANEURYSM CHARACTERISTICS
The study was comprid of challenging aneurysms that are dif?cult to treat successfully with traditional treatments.3,4
t Large or giant wide-necked aneurysms t Saccular or fusiform
t Petrous to superior hypophyal ICA
0% rate of recurrence for completely occluded aneurysms during trial.2
PRIMARY EFFICACY ENDPOINT 2
SECONDARY EFFICACY ENDPOINT 2PRIMARY SAFETY ENDPOINT 2
A
The study enrolled 110 aneurysms. Four were excluded becau of wrong location/size or access not obtained. 106 aneurysms were included in the primary efficacy endpoint analysis. B Seven patients without 6-month angiographic follow-up were excluded from this analysis. C Eight additional patients without 1-year angiographic follow-up were excluded from this analysis. D Includes all patients with attempted treatment. 108 patients were enrolled. One patient was excluded from analysis becau of an access failure. 107 patients were included in the primary safety endpoint analysis. 1009080706050403020100
% of Aneurysms with Complete Occlusion without >50% Stenosis
or Alternative Treatment
% of Aneurysms with Complete Occlusion
% of Patients with Major Stroke or Neurologic Death at 180 Days
PRE-SET TARGET RATE
PRE-SET TARGET RATE
180 days
1 year 180 days 180 days
81.8%
= 81/99B
85.7%
= 78/91C
73.6%
= 78/106A
5.6%
= 6/107D
Results may vary. Not all patients receive the same results.
This device should be ud only by physicians trained in percutaneous, intravascular techniques and procedures at medical facilities with the appropriate ?uoroscopy equipment. The Pipeline ? embolization device should be ud by physicians who have received appropriate training for this device.
Indications for U: The Pipeline ? embolization device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyal gments. CAUTION: Federal (USA) law restricts this device to sale, distribution and u by or on the order of a physician. CONTRAINDICATIONS: The u of the Pipeline ? embolization device is contraindicated for patients with any of the following conditions: 1) Patients with an active bacterial infection; 2) Patients in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated; 3) Patients who have not received dual antiplatelet agents prior to the procedure; or 4) Patients in whom a pre-existing stent is
in place in the parent artery at the target aneurysm location. WARNINGS: 1) While advancing the Pipeline ? embolization device inside the microcatheter, do not pull back or torque the wire. This may make device relea more dif?cult or impossible; 2) Do not rotate the delivery wire for more than 10 full turns. Over-rotation may cau delivery wire breakage. If the Pipeline ? embolization device does not open after 10 turns, remove the entire system (microcatheter and Pipeline ? embolization device delivery system) simultaneously; 3) If the capture coil tip of the delivery system becomes stuck in the mesh of a delivered Pipeline ? embolization device, rotate the wire clockwi while advancing the wire to try to relea it, then slowly pull back on the delivery wire; 4) Persons with known allergy to platinum or cobalt/chromium alloy (including the major elements Platinum, Cobalt, Chromium, Nickel or Molybdenum) may suffer an allergic reaction to the Pipeline ? embolization device.Images of devices are for illustrative purpos only and may vary from ?nalized sterile product.
References: 1. Kallmes DF , Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A cond-generation, endoluminal, ?ow-disrupting device for treatment of saccular aneurysms. AJNR Am J Neuroradiol. 2009;30(6):1153-1158. 2. PUFs FDA Summary of Safety and Effectiveness Data (SSED) 3. The International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured Intracranial Aneurysms – Risk of Rupture and Risks of Surgical Intervention. Neuroradiology. N Engl J Med 1998;
339:1725-1733 4. ISAT: International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping vs endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomized trial. The Lancet, Vol 360, Oct 2002.
Product Number
Vesl Diameter (mm)Length (mm)FA-77250-10, -12, -14, -16, -18, -20 2.5010, 12, 14, 16, 18, 20FA-77275-10, -12, -14, -16, -18, -20 2.7510, 12, 14, 16, 18, 20FA-77300-10, -12, -14, -16, -18, -20 3.0010, 12, 14, 16, 18, 20FA-71300-25, -30, -35
3.0025, 30, 35
FA-77325-10, -12, -14, -16, -18, -20 3.2510, 12, 14, 16, 18, 20FA-71325-25, -30, -35
3.2525, 30, 35
FA-77350-10, -12, -14, -16, -18, -20 3.5010, 12, 14, 16, 18, 20FA-71350-25, -30, -35
3.5025, 30, 35
FA-77375-10, -12, -14, -16, -18, -20 3.7510, 12, 14, 16, 18, 20FA-71375-25, -30, -35
3.75
25, 30, 35
Product Number
Vesl Diameter (mm)Length (mm)FA-77400-10, -12, -14, -16, -18, -20 4.0010, 12, 14, 16, 18, 20FA-71400-25, -30, -35
4.0025, 30, 35
FA-77425-10, -12, -14, -16, -18, -20 4.2510, 12, 14, 16, 18, 20FA-71425-25, -30, -35
4.2525, 30, 35
FA-77450-10, -12, -14, -16, -18, -20 4.5010, 12, 14, 16, 18, 20FA-71450-25, -30, -35
4.5025, 30, 35
FA-77475-10, -12, -14, -16, -18, -20 4.7510, 12, 14, 16, 18, 20FA-71475-25, -30, -35
4.7525, 30, 35
FA-77500-10, -12, -14, -16, -18, -20 5.0010, 12, 14, 16, 18, 20FA-71500-25, -30, -35
5.00
25, 30, 35
Catalog Number Outer Diameter Distal/Proximal
Inner Diameter
Working Length
Distal Flexible Length
FA-55135-1030 2.8F/3.2F 0.027 in 135 cm 10 cm FA-55150-1030
2.8F/
3.2F
0.027 in
150 cm
10 cm
Pipeline ? Embolization Device
Marksman ? Micro Catheter
COVIDIEN, COVIDIEN with logo and Covidien logo are US and
internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ? 2012 Covidien. 76665-001 (A) SEP/12
T W I , CA USA
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